Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/238
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Dextrose (Injection, Solution)
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The dose is dependent on the age, weight and clinical
condition of the patient. As reported in
the literature, the dosage and constant infusion rate of intravenous
dextrose must be selected with caution in pediatric patients, particularly
neonates and low birth weight infants, because of the increased risk
of hyperglycemia/hypoglycemia. Parenteral
drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit. See PRECAUTIONS.
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| dailymed-instance:descripti... |
5% Dextrose Injection, USP solution is sterile and
nonpyrogenic. It is a parenteral solution containing 50 mg/mL of dextrose,
hydrous in water for injection and is intended for intravenous administration
after admixing with an ADD-Vantage vial. The
solution contains no bacteriostat, antimicrobial agent or added buffer
and is intended only as a single-dose injection. When smaller doses
are required the unused portion should be discarded. The solution is slightly hypotonic (253 mOsmol/liter; calc.)
in relation to the extracellular fluid (approx. 280 mOsmol/liter).The pH of the solution is 4.3 (3.2���6.5). The solution is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose,
monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following
structural formula: Water for Injection, USP is chemically designated HO. The flexible plastic container is fabricated
from a specially formulated polyvinylchloride. Water can permeate
from inside the container into the overwrap but not in amounts sufficient
to affect the solution significantly. Solutions in contact with the
plastic container may leach out certain chemical components from the
plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. Exposure to temperatures
above 25��C/77��F during transport and storage will lead to
minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically
significant changes within the expiration period.
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When administered intravenously, this solution provides
a source of water and carbohydrate. Solutions
containing carbohydrate in the form of dextrose restore blood glucose
levels and provide calories. Carbohydrate in the form of dextrose
may aid in minimizing liver glycogen depletion and exerts a protein-sparing
action. Dextrose injected parenterally undergoes oxidation to carbon
dioxide and water. Water is an essential
constituent of all body tissues and accounts for approximately 70%
of total body weight. Average normal adult daily requirements range
from two to three liters (1.0 to 1.5 liters each for insensible water
loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms.
Water distribution depends primarily on the concentration of electrolytes
in the body compartments and sodium (Na) plays a major
role in maintaining physiologic equilibrium.
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Dextrose Injection without electrolytes should not
be administered simultaneously with blood through the same infusion
set because of the possibility that pseudoagglutination of red cells
may occur.
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| dailymed-instance:supply |
5% Dextrose Injection, USP is supplied in 50, 100
and 250 mL single-dose flexible plastic ADD-Vantage diluent containers (List No. 7100). Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] INSTRUCTIONS FOR USE These instructions
for use should be made available to the individuals who perform the
reconstitution steps. To Open: Peel overwrap
at corner and remove solution container. Some opacity of the plastic
due to moisture absorption during the sterilization process may be
observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique) To Reconstitute the Drug: If the rubber stopper is not removed from the vial
and medication is not released on the first attempt, the inner cap
may be manipulated back into the rubber stopper without removing the
drug vial from the diluent container. Repeat steps 3 through 5. Preparation for Administration: (Use Aseptic Technique) WARNING: Do not use flexible
container in series connections. U.S.
patent 4,757,911 April, 2006
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| dailymed-instance:precautio... |
Clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations
and acid-base balance during prolonged parenteral therapy or whenever
the condition of the patient warrants such evaluation. Solutions containing dextrose should be used with
caution in patients with known subclinical or overt diabetes mellitus. Do not administer unless solution is clear and container
is undamaged. Discard unused portion.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility:: Studies with solutions from ADD-Vantage flexible
plastic containers have not been performed to evaluate carcinogenic
potential, mutagenic potential or effects on fertility.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted
with dextrose. It is also not known whether dextrose can cause fetal
harm when administered to a pregnant woman or can affect reproduction
capacity. Dextrose should only be given to a pregnant woman if clearly
needed.<br/>Nursing Mothers:: Caution should be exercised when solutions from ADD-Vantage
flexible containers are administered to a nursing woman.<br/>Pediatric Use:: The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric
and adult populations. In neonates or very small infants the volume
of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required
when dextrose is prescribed to pediatric patients, particularly neonates
and low birth weight infants. In very low
birth weight infants, excessive or rapid administration of dextrose
injection may result in increased serum osmolarity and possible intracerebral
hemorrhage. Only additives in the ADD-Vantage
vial should be delivered via this solution.
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| dailymed-instance:overdosag... |
In the event of overhydration or solute overload,
re-evaluate the patient and institute appropriate corrective measures.
See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
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| dailymed-instance:genericMe... |
Dextrose monohydrate
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| dailymed-instance:fullName |
Dextrose (Injection, Solution)
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| dailymed-instance:adverseRe... |
Reactions which may occur because of the solution
or the technique of administration include febrile response, infection
at the site of injection, venous thrombosis or phlebitis extending
from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the
infusion, evaluate the patient, institute appropriate therapeutic
countermeasures and save the remainder of the fluid for examination
if deemed necessary.
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| dailymed-instance:warning |
Excessive administration of potassium-free solutions
may result in significant hypokalemia. The
intravenous administration of these solutions can cause fluid and/or
solute overloading resulting in dilution of serum electrolyte concentrations,
overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the
electrolyte concentrations of administered parenteral solutions. The
risk of solute overload causing congested states with peripheral and
pulmonary edema is directly proportional to the electrolyte concentrations
of such solutions.
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Intravenous solutions containing dextrose are indicated
for parenteral replenishment of fluid and minimal carbohydrate calories
as required by the clinical condition of the patient. In this dosage form, 5% Dextrose Injection, USP is intended to
be used as a diluent for the contents of an ADD-Vantage vial.
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| dailymed-instance:name |
Dextrose
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